U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. For Industry
  3. FDA Data Standards Advisory Board
  4. Structured Product Labeling Resources
  5. Risk Evaluation and Mitigation Strategies (REMS) SPL Resources
  1. Structured Product Labeling Resources

Risk Evaluation and Mitigation Strategies (REMS) SPL Resources

 

 

Instructions for Sending a Test REMS SPL Document to FDA

To initiate the process of submitting a REMS SPL test submission, send the following details to spl@fda.hhs.gov:

  • Contact’s Name
  • Contact’s Company Name
  • Contact’s Phone Number
  • Contact’s Email Address
  • Planned Date of Official Submission

REMS SPL test submissions should be submitted through the Test Electronic Submissions Gateway "OC" "center".

 

REMS SPL Sample

Back to Top